CONTRAINDICATIONS
Severe allergic reactions (e.g., anaphylaxis) to any component of CERVARIX.
WARNINGS AND PRECAUTIONS
Syncope
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Latex
The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper does not contain latex.
Preventing and Managing Allergic Vaccine Reactions
Prior to administration, the healthcare provider should review the immunization history for possible vaccine hypersensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision should be readily available in case of anaphylactic reactions following administration of CERVARIX.
POSTMARKETING EXPERIENCE
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for CERVARIX since market introduction (2007) are listed below. This list includes serious events or events which have suspected causal association to CERVARIX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.
Blood and Lymphatic System Disorders:
Lymphadenopathy.
Immune System Disorders:
Allergic reactions (including anaphylactic and anaphylactoid reactions),
Angioedema,
Erythema multiforme.
Nervous System Disorders:
Syncope or vasovagal responses to injection (sometimes accompanied by tonic-clonic movements).
PATIENT COUNSELING INFORMATION
Provide the Vaccine Information Statements prior to immunization. This is required by the National Childhood Vaccine Injury Act of 1986 and are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
Inform the patient, parent, or guardian:
Vaccination does not substitute for routine cervical cancer screening. Women who receive CERVARIX should continue to undergo cervical cancer screening per standard of care.
CERVARIX does not protect against disease from HPV types to which a woman has previously been exposed through sexual activity.
Since syncope has been reported following vaccination in young females, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.
Information regarding potential benefits and risks associated with vaccination.
Report any adverse events to their healthcare provider.
Safety has not been established in pregnant women.
CERVARIX is not recommended for use in pregnant women or women planning to become pregnant during the vaccination course.
Register women who receive CERVARIX while pregnant in the pregnancy registry by calling 1-888-452-9622.
